NCT00075101已完成3 期
Sleep, Fatigue, and Dexamethosone in Childhood Cancer
National Institute of Nursing Research (NINR)1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2000年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Fatigue and sleep quality changes
研究概览
简要总结
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
详细描述
Approximately 134 children and adolescents will be enrolled. All children and adolescents will wear a wrist actigraph for two consecutive 5-day study periods. Children and adolescents will have blood drawn 2 times on Day 1 when they are on dexamethosone. Their parents will complete a sleep diary and fatigue questionnaire by telephone on Days 2 and 5 of both study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study Cycle
Experimental
干预措施: Dexamethosone (Drug)
结局指标
主要结局
Fatigue and sleep quality changes
时间窗: 10 days
次要结局
- Pharmacogenetics with dextamethasone use(5 days)
- Pharmacokinetics with dextamethasone use(5 days)
研究者
研究点 (1)
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